A Post Marketing Surveillance Study to monitor the reactogenicity and safety of Vaxem™Hib when administered according to the prescribing information in Korea

ovartis Vaccines and Diagnostics0 个研究点目标入组 750 人开始时间: 2014年12月10日最近更新: 2015年1月6日

适应症

试验速览

暂无简介。

•1.Male and female children, 2 months to 5 years of age, who are scheduled to receive vaccination to prevent Haemophilus influenzae type b
•2.Individuals in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator
•3.After the nature of the study has been explained according to local regulatory requirements, documented informed consent from parent(s) and/or legally authorized caretaker(s) of the child
•4.Ability to comply with all study procedures and follow-up as scheduled in the study protocol
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 750
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.The Investigator and research staff should review the Vaxem™Hib vaccine Korean Prescribing information to verify that no contraindications, special warnings and/or precautions are indicated for any subject prior to enrolment.

发起方

ovartis Vaccines and Diagnostics